MOXIFLOXACIN HYDROCHLORIDE

In shortageOrange BookUNIISPLATC J01MA14

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMylan Institutional LLC

CountryUS (United States)

ATC codeJ01MA14

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6745732325
1 BAG in 1 CARTON (67457-323-25) / 250 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

C53598599T

MOXIFLOXACIN HYDROCHLORIDE

RxCUI 228750

Orange Book

A205833

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Moxifloxacin Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "C53598599T",
    "rxcui": "228750",
    "inchikey": "IDIIJJHBXUESQI-DFIJPDEKSA-N",
    "display_name": "MOXIFLOXACIN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "c6fa4129-2f92-4179-ac5d-bb7b4a538789": {
      "match": "brand_token",
      "title": "MOXIFLOXACIN HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]",
      "spl_version": "9",
      "published_date": "2026-05-21"
    }
  },
  "productid": "67457-323_4719ed2a-9c0b-466a-90ee-a5f9f305cd02",
  "productndc": "67457-323",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "205833",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "400MG/250ML (1.6MG/ML)",
        "product_no": "001",
        "approval_date": "May 5, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MOXIFLOXACIN HYDROCHLORIDE",
  "shortage_reason": "Moxifloxacin Injection",
  "shortage_status": "current",
  "proprietary_name": "MOXIFLOXACIN HYDROCHLORIDE",
  "active_ingred_unit": "mg/250mL",
  "application_number": "ANDA205833",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MOXIFLOXACIN HYDROCHLORIDE",
  "start_marketing_date": "20171003",
  "active_numerator_strength": "400"
}

Related drugs

Other records sharing ATC code J01MA14.

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